Effect of Two Different Digital Construction Techniques of Implant-assisted Overdentures

NCT ID: NCT06720389

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-12
• Study Completion Date: 2024-11-06

Brief Summary

twenty patients received mandibular overdenture constructed by different construction techniques were classified equally and randomly into two groups peri implant bone loss was assessed by CBCT at baseline (T0), at1 year(T1), at 3 years(T3) and posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.

Detailed Description

twenty patients received mandibular overdenture constructed by different construction techniques were classified equally and randomly into two groups (n = 10 per group): Group A: received milled mandibular overdenture opposed by maxillary complete denture. Group B: received 3D-printed mandibular overdenture opposed by maxillary acrylic complete denture. peri implant bone loss was assessed by CBCT at baseline (T0), at1 year(T1), at 3 years(T3) and posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.

Conditions

Peri Implant Bone Loss

Keywords

Milled denture base; 3D-printing denture base,

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

milled mandibular overdenture opposed by maxillary complete denture

A denture base milled from a pre-polymerized block of polymethylmethacrylate (Ivobase CAD) along with milled denture teeth from a block of tooth coloured material PMMA (SR Vivodent CAD).

Group Type: ACTIVE_COMPARATOR

peri implant bone loss was assessed by CBCT

Intervention Type: RADIATION

using CBCT, vertical bone loss (VBL) was measured at baseline (T0), at1 year(T1), at 3 years(T3)

posterior ridge resorption was assessed by CBCT

Intervention Type: OTHER

posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.

3D-Printed mandibular overdenture

The printer (Rasdent 3d printer) was loaded with material of 3D-printed denture base and 3D- printed denture teeth (Dentca denture teeth shade A2). The mandibular denture teeth were printed as one unit then bonded to the lower printed denture base.

Group Type: ACTIVE_COMPARATOR

peri implant bone loss was assessed by CBCT

Intervention Type: RADIATION

using CBCT, vertical bone loss (VBL) was measured at baseline (T0), at1 year(T1), at 3 years(T3)

posterior ridge resorption was assessed by CBCT

Intervention Type: OTHER

posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.

Interventions

peri implant bone loss was assessed by CBCT

using CBCT, vertical bone loss (VBL) was measured at baseline (T0), at1 year(T1), at 3 years(T3)

Intervention Type: RADIATION

posterior ridge resorption was assessed by CBCT

posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All patient wearing maxillary conventional denture.
• All patients had temporary mandibular overdenture supported by vertically inserted 4-implant at least six months ago.
• A Cone Beam Computed Tomography (CBCT) done to verify the accurate position and success of the inserted implant.
• They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This was achieved through medical history and clinical examination by physician.
• At least 15 mm restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane) to permit construction of all types of tested prosthesis (class I according to Ahuja and Cagna). This was detected by a tentative jaw relation.
• All patients are of angel's class I maxillo-mandibular relationships.

Exclusion Criteria

• Patients had head and neck radiotherapy, patients with bleeding disorders or hepatic patients.
• Patients with metabolic disorders as diabetes mellitus, osteoporosis and hepatic disorders that might affect osseointegration.
• Long term immunosuppress and corticosteroid drug therapy.
• Patient with abnormal habits as clenching and bruxism.
• Smoking patient.
• Uncooperative patients.
• Neuromuscular diseases.
• Patient with problems in TMJ.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mansoura University

Al Mansurah, , Egypt

Countries

Egypt

References

El Khamisy NES, Emera RMK, Elmanci TM, Aboelez MA. Effect of two different digital construction techniques of mandibular implant-assisted overdentures on peri-implant bone loss and posterior ridge resorption: a 3-year prospective randomized clinical trial. BMC Oral Health. 2025 Jul 2;25(1):1040. doi: 10.1186/s12903-025-06425-0.

Reference Type: DERIVED

PMID: 40604700 (View on PubMed)

Other Identifiers

A01010024RP

Identifier Type: -

Identifier Source: org_study_id